Pharmacokinetics of Dexamethasone in Childhood ALL and Reduction in Bone Mineral Density

Recruiting

• Conditions: Acute Lymphoblastic Leukemia

• Registration Number: NCT06367725
• Lead Sponsor: University of Aarhus

Brief Summary

The goal of this observational study is to learn about, the systemic exposure to dexamethason in childhood acute lymphatic leukemia (ALL). The main questions it aims to answer are:

* How does the intake of dexamethasone correlate with systemic exposure to dexamethason?

* Does systemic exposure to dexamethasone correlate with a reduction in bone mineral density?

Participants will:

* Continue to receive the best available therapy for ALL in Western Europe.

* Have blood samples taken from their central line to measure dexamethasone levels.

* When standard lumbar punctures are done as part of treatment, a sample of cerebrospinal fluid will also be taken to analyze dexamethasone.

* Visit the clinic four times for a DXA scans to measure bone density and vertebral fracture assessment: within three weeks of starting treatment, six months after starting treatment, one month after finishing treatment, and one year after finishing treatment. Biomarkers related to bone health will also be collected on these days. Additionally, participants will fill out questionnaires to track their daily physical activity levels.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-04-11
• Study First Submitted: 2024-04-11
• Study First Submitted QC: 2024-04-11
• Last Update Submitted: 2024-04-11
• Study First Posted: 2024-04-16
• Last Update Posted: 2024-04-16
• Primary Completion: 2027-12-30
• Study Completion: 2030-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• A diagnosis of acute lymphoblastic leukaemia
• Age 1-17.9 years

Exclusion Criteria

• Down syndrome

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration Curve (AUC) of Dexamethasone	Repeated during induction, with AUC measurements on days 3, 4, and 15. Blood samples taken before dosing, and after 1, 2, 4, and 6 hours	Blood samples

Secondary Outcome Measures

Name	Time	Method
Dexamethasone in cerebrospinal fluid	When lumbar punctures are performed according to standard treatment during induction	Comparing measurements of dexamethasone in blood and cerebrospinal fluid
Vertebral fracture assessment (VFA) by DXA-scan	Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.	DXA-scan
Mineral bone density by DXA-scan	Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.	DXA-scan

Trial Locations

Locations (4)

Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital; 🇩🇰 Aarhus N, Denmark

Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital Rigshospitalet; 🇩🇰 Copenhagen, København Ø, Denmark

Department of Paediatrics and Adolescent Medicine, Odense University Hospital; 🇩🇰 Odense, Odense C, Denmark

Department of Paediatrics and Adolescent Medicine, Aalborg University Hospital; 🇩🇰 Aalborg, Denmark